Efficacy of Adjunctive Low-Level Light Therapy to Intense Pulsed Light for Meibomian Gland Dysfunction

November 3, 2024 updated by: Chulalongkorn University

The goal of this clinical trial is to compare the effectiveness of adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) versus intense pulsed light (IPL) alone for the treatment of meibomian gland dysfunction (MGD).

The main question it aims to answer is does the adjunctive of low-level light therapy (LLLT) to intense pulsed light (IPL) provide more beneficial treatment effects than intense pulsed light (IPL) alone in treating meibomian gland dysfunction (MGD) patients?

Participants will be randomized into 2 groups: adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) group (ALLLT +IPL) and IPL alone group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In both the IPL group and the ALLLT+IPL group, the doctor will administer IPL therapy to each participant and apply the Light Modulation® special facial mask to their faces. The assistant nurse will activate the light power, ensuring that the doctor remains blind to treatment allocation. Participants in both groups will receive a conventional treatment for MGD including warm compression and lid hygiene. Moreover, all participants will be advised to use preservative-free artificial tears 4 times daily throughout the study.

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • MGD severity level 2 and above according to the international workshop on MGD
  • Fitzpatrick skin type of 1-4 according to sun sensitivity characteristics and appearance of the skin color

Exclusion Criteria:

  • History of previous ocular trauma or surgery within the past six months
  • Contact lens-wearing patients
  • Patients with skin-pigmented lesions in the treatment area
  • Pregnancy or breastfeeding patients
  • Patients with any uncontrolled ocular or systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALLLT + IPL group
Participants will receive a session of IPL therapy followed by LLLT therapy, once weekly for 4 weeks (total 4 treatment sessions). The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim. The LLLT therapy will be delivered using the Light Modulation® special facial mask (Espansione Marketing S.p.A., Bologna, Italy) which will be placed on the participant's face for 15 minutes. The mask has the shape of a half-face and will emit a red light in a light-emitting diode (LED) system.
Device: Low-level light therapy (LLLT)
LLLT therapy will be delivered using the Light Modulation® special facial mask (Espansione Marketing S.p.A., Bologna, Italy) which will be placed on the participant's face for 15 minutes. The mask has the shape of a half-face and will emit a red light in an LED system. The device has an emission power of 100 The mask has the shape of a half-face and will emit a red light in a light-emitting diode (LED) system. The device has an emission power of 100 milliwatts per square centimeter.
Device: Intense pulsed light (IPL)
The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim
Active Comparator: IPL alone group
The IPL alone group will receive only a session of IPL therapy, once weekly for 4 weeks (total 4 treatment sessions). The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim, similar to the combined group. Additionally, the special facial mask will also be placed on the participant's face for 15 minutes with no light power applied.
Device: Intense pulsed light (IPL)
The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid layer thickness (LLT)
Time Frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Lipid layer thickness will be evaluated using Lipiview® II interferometer (TearScience®, Johnson & Johnson Vision, California, USA). The thickness of the lipid layer is then calculated from the interference pattern and expressed in interferometric color units (ICU), where 1 ICU reflects approximately 1 nm of lipid layer thickness.
baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meibum quality score
Time Frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Meibum quality grade will be evaluated on central 8 glands at the lower lid with grade 0 indicating clear meibum, 1 indicating cloudy meibum, 2 indicating cloudy particulate meibum, and 3 indicating inspissated, like toothpaste meibum.
baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Meibum expressibility score
Time Frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Meibum expressibility score will be evaluated on central 8 glands at the lower lid with 0 indicating all glands expressible, 1 indicating 3-4 glands expressible, 2 indicating 1-2 glands expressible, and 3 indicating no gland expressible.
baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Meiboscore
Time Frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Meibography will be evaluated using Lipiview® II interferometer (TearScience®, Johnson & Johnson Vision, California, USA) Meiboscore will be graded according to meibomian gland dropout; grade 0 indicates no loss of meibomian gland, grade 1 indicates less than 25% gland loss, grade 2 indicates 25-50% gland loss, grade 3 indicates 50-75% gland loss, and grade 4 indicates more than 75% gland loss.
baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Tear film break-up time (TBUT)
Time Frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
TBUT will be measured using the standard fluorescein staining method.
baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Conjunctival and corneal staining:
Time Frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Conjunctival and corneal staining will be evaluated using National Eye Institute (NEI) industry scale ranging from 0-33.
baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Ocular surface disease index (OSDI) scores
Time Frame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
OSDI scores will be evaluated using a validated questionnaire, with a total score ranging from 0-100. Higher values indicating greater symptom severity; normal (<12), mild (13-22) moderate (23-32) or severe (33-100).
baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Tear cytokines levels
Time Frame: baseline and 12 weeks post treatment
Tear samples were collected using a Schirmer strip placed at the inferior fornix without anesthesia waiting for 5 minutes, then the strip will be kept in a 2 ml centrifuge tube. The samples were stored at -20°C for further assays.
baseline and 12 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Chatchada Kharuhayothin, Ophthalmology department, Faculty of medicine, Chulalongkorn university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

June 16, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0666/66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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